EUCTR2017-001992-22-GB进行中（未招募）1 期
Phase II open label randomised safety and efficacy study of the viral vectored ChAd-MVA 5T4 vaccine in combination with PD-1 checkpoint blockade in low- or intermediate-risk localized or locally advanced prostate cancer and advanced metastatic prostate cancer - VAccination in early and ADvanced prostate caNCEr (ADVANCE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Low- or intermediate-risk prostate cancer group:
- •- Males aged over 18 years
- •-Histologically confirmed adenocarcinoma of the prostate
- •-Clinically localised or locally advanced disease deemed operable by the treating consultant urological surgeon i.e.:
- •Gleason score = 7
- •Local tumour stage =T3c and deemed operable
- •No evidence of metastases (Nx/N0 and Mx/M0)
- •No evidence of high grade Gleason 5 disease
- •PSA = 20 ng/ml
- •-Scheduled for and considered fit for radical prostatectomy
- •-Absence of any indication to perform urgent surgery that would not allow completion of the study interventions prior to radical prostatectomy
- •Metastatic prostate cancer groups:
- •-Males aged over 18 years
- •-Histologically confirmed adenocarcinoma of the prostate cancer. Note, any Gleason grade or primary tumour staging at diagnosis is permitted.
- •-Evidence of at least one distant metastasis based on MRI, CT, PET or bone scintigraphy.
- •-Established on and suitable to continue with androgen deprivation therapy (ADT) using any luteinizing hormone releasing hormone (LHRH) agonist. LHRH agonist therapy may include goserelin (Zoladex®), leuprorelin acetate (Prostap®) or any other licenced product in this class.
- •-On treatment with anti-androgen therapy using either abiraterone (Zytiga®) or enzalutamide (Xtandi®) and demonstrating evidence of disease progression at the time of enrolment, defined according Prostate Cancer Working Group 2 Criteria as either:
- •increasing PSA or;
- •progressive nodal or visceral disease or;
- •progressive bone metastases
- •-Suitable to continue therapy with either abiraterone or enzalutamide at the time of enrolment
- •-Satisfactory functional status defined as Eastern Cooperative Oncology Group (ECOG) Performance Status
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •All participants:
- •The patient may not enter the study if any of the following apply:
- •-Any prior diagnosis or clinical suspicion of autoimmune disease including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, vasculitis, Grave’s disease and type I diabetes mellitus. Note, subjects with known pre-existing clinically silent positive autoantibodies should not be included.
- •-Any diagnosis of a non-prostate malignancy within the last 3 years where in the opinion of the investigator the risk of recurrence exceeds 30%
- •-Participation in another research study involving an investigational product or investigational surgical procedure in the 30 days preceding enrolment, or planned use during the study period
- •-Any prior exposure to checkpoint inhibitor drugs including anti-PD-1, anti-PD-L1, or anti-CTLA-4 monoclonal antibodies or any prior treatment with investigational vaccines
- •- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, e.g. egg products
- •-Administration of immunoglobulins and/or any blood products within the one month preceding the planned administration of the study drugs
- •-Seropositive for Hepatitis B (HBV) Hepatitis C virus (HCV), human immunodeficiency virus (HIV)
- •-Any confirmed or suspected immunocompromised state, including but not limited to, asplenia, a history of atypical, recurrent or severe infections, or, regular use (> 14 days) of systemic immunosuppressant medication within the past 6 months.
- •-Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- •-History of anaphylaxis in relation to vaccination or any clinically significant allergic disease likely to be exacerbated by any component of the vaccine or checkpoint inhibitor preparations, as listed in the Investigator’s Brochure and SmPC
- •-Confirmed or suspected recreational drug use or harmful drinking in the last 5 years
- •-History of a serious psychiatric condition or other circumstances that may be associated with impaired mental capacity
- •-Other prior malignancy with an estimated = 30% chance of relapse within 2 years. Allowed recent cancers include (but are not limited to) non-melanomatous skin cancer and superficial bladder cancer
- •-Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigating physician increases the level of risk to the patient, limits the ability of the patient to participate in the study or impairs interpretation of the study data
- •Exclusion Criteria – Metastatic prostate cancer groups
- •The volunteer may not enter the metastatic prostate cancer arm of the study if:
- •-The treating oncologist or urological cancer MDT estimates a subject’s life expectancy to be = 6 months
- •-Any active, previously treated, or suspected intracranial or leptomeningeal metastases
研究者
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